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A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Transplantation

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Trial Information

A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab


Inclusion Criteria:



- adult patients greater than 18 years of age

- recipients of primary kidney transplant

- single-organ recipients (kidney only)

Exclusion Criteria:

- previous treatment with Zenapax

- history of malignancy (except localized skin cancer)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Renal function (as measured by GFR)

Outcome Time Frame:

12 months post-transplant

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

M67005

NCT ID:

NCT00048152

Start Date:

December 2000

Completion Date:

March 2006

Related Keywords:

  • Kidney Transplantation

Name

Location

Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Philadelphia, Pennsylvania  19104
McLean, Virginia  22101
Hackensack, New Jersey  07601
Charleston, South Carolina